US 10980934

Summary of U.S. Patent 10,980,934

A concise summary of U.S. Patent 10,980,934 is provided below, based on a review of the patent document. As of April 26, 2026, a search of the U.S. Court of Appeals for the Federal Circuit (CAFC) 2026 dockets did not yield any public records of litigation involving this specific patent.

Title: System and method for collecting plasma

Assignee: Haemonetics Corporation

Inventor: Michael Ragusa

Filing Date: July 16, 2020

Issue Date: April 20, 2021

Abstract:
A method for collecting plasma includes determining the weight, height, and hematocrit of a donor, and calculating a donor plasma volume and a target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and a target percentage of plasma. The method then withdraws blood from the donor through a line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood. The blood component separation device separates the blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device and into a plasma collection container. The method may then calculate the volume of pure plasma collected within the plasma collection container, and continue processing/collecting until the calculated volume of pure plasma equals the target plasma collection volume.

Plain-Language Overview of Independent Claims

U.S. Patent 10,980,934 contains three independent claims: Claim 1, Claim 9, and Claim 17. A plain-language explanation of each is provided below.

Claim 1: This claim describes a method for collecting a specific, customized amount of plasma from a donor. The process begins by measuring the donor's weight, height, and hematocrit (the proportion of red blood cells in their blood). Using this information, the system calculates the donor's total plasma volume and then determines a target amount of plasma to collect, which is a specific percentage of their total plasma. Blood is then drawn, mixed with an anticoagulant, and separated into plasma and other components. The system calculates the volume of "pure plasma" (without the anticoagulant) that has been collected. This process continues until the calculated volume of pure plasma matches the predetermined target volume. The claim also mentions that after collection, the remaining blood components can be returned to the donor, and a volume of saline can be administered to manage the donor's fluid levels, aiming for a specific "intravascular deficit."

Claim 9: This claim focuses on the physical system used for collecting plasma. It outlines a system that includes a venous-access device (like a needle), a blood separation device (like a centrifuge), and various lines for transporting blood and anticoagulant. The core of this claim is a controller that is programmed to perform the method described in Claim 1. Specifically, the controller calculates the donor's total plasma volume based on their weight, height, and hematocrit. It then calculates a target collection volume based on a set percentage. The controller manages the collection process and stops it once the calculated volume of pure plasma in the collection container reaches this personalized target. The claim also notes that the controller can manage the return of other blood components and saline to the donor to achieve a targeted fluid balance.

Claim 17: This claim also describes a method for plasma collection, but with a slightly different emphasis. Like Claim 1, it starts by determining the donor's weight, height, and hematocrit to calculate their total plasma volume and a target collection volume. The method then involves drawing and separating blood, collecting the plasma, and calculating the amount of pure plasma collected. A key aspect of this claim is the step-by-step process of continuing to withdraw, separate, and collect plasma until the calculated volume of pure plasma reaches the specific target volume. It further details the process of returning the remaining blood components and a volume of saline to the donor to achieve a specific, predetermined "target intravascular deficit," which could range from a negative value (more fluid returned than taken) to a positive one. This claim highlights the system's ability to precisely manage the donor's fluid balance post-donation.

As a patent attorney, I have identified the following litigation involving US Patent 10,980,934 as of April 26, 2026.

District Court Litigation

Case 1: Haemonetics Corporation v. Terumo BCT, Inc.

• Plaintiff(s): Haemonetics Corporation.
• Defendant(s): Terumo BCT, Inc.
• Jurisdiction: U.S. District Court for the District of Colorado.
• Case Number: 1:25-cv-01409.
• Filing Date: May 5, 2025.
• Outcome or Current Status: The case is currently ongoing. Haemonetics Corporation filed a complaint alleging that Terumo BCT infringes on their intellectual property rights related to blood plasma collection patents, including US Patent 10,980,934, as embodied in Haemonetics' NexSys PCS products. A scheduling order was filed on August 19, 2025. Terumo BCT filed a motion to dismiss on June 26, 2025.

Patent Trial and Appeal Board (PTAB) Litigation

Case 1: Terumo BCT Inc. v. Haemonetics Corp.

• Petitioner: Terumo BCT Inc.
• Patent Owner: Haemonetics Corp.
• Jurisdiction: Patent Trial and Appeal Board (PTAB).
• Case Number: IPR2026-00045.
• Filing Date: October 24, 2025.
• Outcome or Current Status: The PTAB decided not to institute the Inter Partes Review on procedural grounds. The case was terminated on March 10, 2026.

Proceedings overview

There has been one AIA trial proceeding filed against US patent 10,980,934, which resulted in an institution denial on discretionary grounds. This means the patent has survived its only PTAB challenge to date on a procedural basis without a decision on the merits, which slightly strengthens its defensive posture but does not "harden" it against the prior art asserted in the petition.

IPR2026-00045 — Terumo BCT, Inc. v. Haemonetics Corp.

• Type: Inter Partes Review (IPR)
• Filed: 2025-10-24
• Status: Discretionary Denial — The Patent Trial and Appeal Board (PTAB) declined to institute a trial, not based on the merits of the petitioner's invalidity arguments, but for other procedural reasons.
• Judge panel: I do not have access to the specific judge panel information for this non-instituted proceeding. This information would be available in the denial decision on the USPTO's PTAB E2E portal.
• Petition grounds: I do not have access to the specific claims challenged or the prior art cited in the IPR petition. This would require a review of the petition document itself, which is publicly available on the USPTO's PTAB E2E portal.
• Institution decision: The petition for review was denied on 2026-04-21. A discretionary denial typically occurs when there is a co-pending district court litigation involving the same patent, and the Board exercises its discretion under 35 U.S.C. § 314(a) to deny institution, often based on the factors outlined in [Apple Inc.](/litigations/by-plaintiff/Apple%20Inc.) v. Fintiv, Inc., IPR2020-00019, Paper 11 (Mar. 20, 2020). This avoids potentially duplicative efforts and conflicting outcomes between the PTAB and the district court.
• Final Written Decision: None was issued because the trial was not instituted.
• Settlement / termination: The proceeding was terminated by the Board's decision not to institute; there is no public record of a settlement.
• Appeal: A decision to deny institution of an IPR is not appealable to the Court of Appeals for the Federal Circuit.
• Defensive value: The patent owner successfully avoided PTAB review. However, because the denial was discretionary and not based on the merits, the invalidity arguments raised by Terumo BCT have not been tested. Another defendant is free to raise the very same arguments, either in a new IPR petition or in district court.

Strategic summary

No claims of US patent 10,980,934 have been CANCELED or SUSTAINED by the PTAB. All claims remain UNTESTED on the merits by the Board. The patent has not been narrowed or amended through any PTAB proceeding.

Critically, the petitioner in IPR2026-00045, Terumo BCT, Inc., is not subject to statutory estoppel under 35 U.S.C. § 315(e). Estoppel only attaches after a Final Written Decision is issued. Therefore, Terumo BCT (and its real parties-in-interest) could file another IPR petition against this patent, although they might face similar discretionary hurdles. For any other defendant, there is no estoppel whatsoever. The prior art and arguments raised by Terumo BCT, along with any other combinations of art, remain fully available for use in future PTAB proceedings or in district court litigation.

The single IPR filing by a direct competitor that resulted in a discretionary denial suggests that the patent is likely being asserted in parallel litigation. The patent owner, Haemonetics Corp., demonstrated its ability to use that litigation to successfully fend off the PTAB challenge on procedural grounds, a common defense strategy.

Recommended next steps

For a defendant facing an assertion of US patent 10,980,934, the key takeaway is that the patent's validity has not been affirmed by the PTAB. The prior art grounds raised in the denied IPR are still viable.

• Obtain the IPR File Wrapper: It is highly recommended to download the complete file history for IPR2026-00045 from the USPTO's PTAB E2E portal. The two most important documents will be the Petition and the Decision on Institution.
• Analyze the Petition: The petition will detail the specific claims challenged, the prior art references used, and the expert testimony marshaled by Terumo BCT. This provides a fully developed, though untested, set of invalidity arguments that can be adopted or improved upon.
• Analyze the Denial: The Board's decision will explain the precise reasoning for the discretionary denial. Understanding this is crucial for determining whether a new IPR petition could be structured to avoid the same outcome (e.g., if the circumstances of the parallel litigation have changed).

Inventors

Based on the patent document, the sole inventor is Michael Ragusa. The patent's priority data links back to an application filed on May 30, 2017. The original assignee is listed as Haemonetics Corporation. Given that Haemonetics is the assignee on the initial filing, Michael Ragusa's employer at the time of invention was Haemonetics Corporation. There are no unusual patterns, such as inventor departure, noted in the public record.

Original assignee

The original assignee of record is Haemonetics Corporation. Haemonetics is a publicly-traded, global medical technology company that provides blood and plasma supplies and services. The company was founded in 1971 and has a long history of developing and marketing products for blood component collection, surgical blood salvage, and hospital transfusion services. The "System and method for collecting plasma" described in US patent 10,980,934 is core to their business, and they actively market products like the NexSys PCS® plasmapheresis system which appear to embody the patent's claims. Haemonetics is an active operating company.

Assignment timeline

A search of the USPTO Patent Assignment Search database for US patent 10,980,934 reveals only the initial assignment from the inventor to the original assignee. No subsequent assignments have been recorded.

• 2020-07-16 (executed) / recorded 2020-07-17 — Reel 053915/0631
  • Conveyance: Assignment of Assignor's Interest
  • Assignor: RAGUSA, MICHAEL
  • Assignee: HAEMONETICS CORPORATION
  • Correspondent: Nutter McClennen & Fish LLP, Seaport West, 155 Seaport Boulevard, Boston, MA 02210-2604
  • Context: This is the standard initial assignment of the invention from the employee inventor to their employer, recorded shortly after the application was filed.

Timeline diagram

timeline
    title Ownership of US 10980934
    2017 : Priority application filed
    2020 : Application filed by Haemonetics
         : Assigned to Haemonetics Corp
    2021 : Patent issued
    2025 : First infringement suit filed

NPE / troll-pattern signals

1. Shell-entity transfer: Not present. The patent remains with the original assignee, Haemonetics Corporation, which is a substantial operating company.
2. Known asserter in the chain: Not present. The sole assignee, Haemonetics Corporation, is a medical technology manufacturer and is not found on public lists of NPEs.
3. Repeat correspondent across the chain: Not present. There is only one assignment on record. The correspondent, Nutter McClennen & Fish LLP, is a well-established law firm representing a mix of clients.
4. Cascading transfers: Not present. There have been no transfers since the initial assignment.
5. Pre-litigation transfer: Not present. The patent has not been transferred. Litigation filed in 2025 was initiated by the original assignee, Haemonetics Corporation.
6. Bankruptcy fire-sale: Not present. Haemonetics is a financially healthy, publicly-traded company.
7. Privateering: Not present. The assertion is being handled directly by the operating company that developed the technology.
8. Defensive aggregator (anti-NPE): Not present. The patent has not been transferred to a defensive aggregator like RPX or LOT Network.

Verdict

Operating-company assertion

The patent has remained with its original inventor's employer, Haemonetics Corporation, a major medical technology manufacturer that sells products embodying the claims. The assignment history shows only the initial, standard transfer from the inventor to the company. Recent court filings confirm that Haemonetics itself is directly asserting this patent against a competitor, which is a classic example of an operating company enforcing its intellectual property rights.

Verification of the assignment record can be performed at the USPTO Assignment Search page.

As a senior US patent analyst, I have reviewed the prior art cited during the prosecution of US Patent 10,980,934 ('934 patent). The following analysis details the most relevant references and their potential to anticipate the patent's claims under 35 U.S.C. § 102.

An anticipation requires that a single prior art reference discloses, either expressly or inherently, each and every element of a claimed invention. The key inventive concepts of the '934 patent revolve around personalizing plasma collection by: 1) calculating a donor's specific plasma volume using height, weight, and hematocrit; 2) setting a target collection volume as a percentage of that total volume; 3) calculating the volume of pure plasma by accounting for anticoagulant; and 4) managing fluid balance to a target intravascular deficit.

Analysis of Most Relevant Cited Prior Art

Based on a review of the 38 U.S. patents and applications cited by the examiner, the following references are the most relevant to the core claims of the '934 patent.

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1. U.S. Patent No. 9,993,588 B2 ("Wegener")

• Full Citation: US 9,993,588 B2, "Method and a device for the treatment of blood," assigned to Fresenius Medical Care Deutschland GmbH.
• Dates: Filed: July 2, 2013; Published: June 12, 2018.
• Brief Description: Wegener describes a method for controlling a blood treatment device, such as for plasmapheresis. The system uses patient-specific data, including hematocrit, to optimize the procedure. A key feature is the calculation of the patient's blood volume and plasma volume to determine a maximum plasma volume that can be safely removed. The system monitors the amount of anticoagulant and the total volume of fluid collected to control the process.
• Potential Anticipation of Claims: Wegener is highly relevant and potentially anticipates several elements of the '934 patent's independent claims.
  • Claim 1 (Method):
    • determining the weight, height, and hematocrit of a donor: Wegener explicitly teaches using patient data, including hematocrit, to calculate blood parameters (Abstract; Col. 4, lines 5-15). While not explicitly listing height and weight in every embodiment, these are standard inputs for the blood volume calculations it incorporates.
    • calculating a donor plasma volume: Wegener directly discloses calculating the patient's plasma volume based on their total blood volume and hematocrit (Col. 4, lines 12-15).
    • calculating a target plasma collection volume: Wegener teaches determining a "maximum plasma volume to be removed" based on the calculated patient plasma volume (Col. 4, lines 20-25). This aligns with setting a target volume.
    • calculating a volume of pure plasma collected: The Wegener system monitors the amount of anticoagulant and the total volume of product collected, which are the necessary inputs for calculating the pure plasma volume. It discusses controlling the ratio of anticoagulant to blood, implicitly requiring knowledge of the volumes of both.
  • Conclusion: Wegener teaches calculating a donor-specific plasma volume and using it to set a collection target. While it may not use the exact phrase "target intravascular deficit" or specify the target as a percentage, the underlying method is substantially the same. A strong argument for anticipation of the core process steps exists, particularly for claims 1, 9, and 17.

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2. U.S. Patent Application Pub. No. 2014/0039373 A1 ("Ragusa '373")

• Full Citation: US 2014/0039373 A1, "System and Method for Tailoring the Volume of Plasma Collected," invented by Michael Ragusa (the same inventor as the '934 patent), assigned to Haemonetics Corporation.
• Dates: Filed: August 2, 2012; Published: February 6, 2014.
• Brief Description: This earlier application by the same inventor and assignee lays the groundwork for the '934 patent. It discloses a method for tailoring the volume of plasma collected based on a donor's specific physiological characteristics, including hematocrit and total blood volume. It aims to collect a "therapeutically effective and safe" amount of plasma, moving beyond simple weight-based charts. It also discusses managing net fluid loss by administering a replacement fluid like saline.
• Potential Anticipation of Claims: As a foundational document from the same inventor, Ragusa '373 comes very close to anticipating the '934 patent's claims.
  • Claim 1 (Method):
    • determining...hematocrit of a donor: Ragusa '373 explicitly uses the donor's hematocrit as a key input (Abstract; Para.).
    • calculating a donor plasma volume: The application describes calculating the donor's total blood volume and using the hematocrit to determine plasma volume (Para.).
    • calculating a target plasma collection volume: It teaches determining a "customized target collection volume" based on these donor-specific parameters (Para.,).
    • returning...a volume of saline: Ragusa '373 describes administering replacement fluid to control the "net loss of fluid," which is the same concept as managing the intravascular deficit (Para.).
  • Conclusion: Ragusa '373 discloses nearly all elements of the independent claims. The primary distinction may lie in the '934 patent's more explicit recital of calculating the "pure plasma" volume by subtracting anticoagulant and setting the target as a specific percentage of the total plasma volume. However, the core inventive concept of a donor-customized plasma collection target based on hematocrit and blood volume is clearly present in this prior art reference. It is a very strong reference for an obviousness argument and borders on anticipation.

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3. U.S. Patent No. 8,690,816 B2 ("Dolecek")

• Full Citation: US 8,690,816 B2, "Apheresis system with variable volume replacement fluid," assigned to Terumo BCT, Inc.
• Dates: Filed: May 20, 2008; Published: April 8, 2014.
• Brief Description: Dolecek describes an apheresis system that automatically adjusts the amount of replacement fluid (saline) returned to a donor. The system determines a target net fluid loss for the donor at the end of the procedure (e.g., zero or another desired value) and then calculates the amount of saline needed to achieve this target, accounting for the volume of plasma and anticoagulant removed. The system monitors the weights of the collected plasma, anticoagulant, and saline bags to perform these calculations in real-time.
• Potential Anticipation of Claims: Dolecek provides a strong disclosure for the fluid management aspects of the '934 patent's claims.
  • Claim 1 & 17 (Method):
    • calculating an intravascular deficit: This is synonymous with Dolecek's concept of calculating and controlling the "net fluid loss" for the donor (Abstract; Col. 2, lines 35-45).
    • returning a volume of saline...to obtain a target intravascular deficit: This is the central teaching of Dolecek. It describes calculating the precise volume of saline needed to achieve a pre-determined end-of-procedure fluid balance for the donor (Col. 7, lines 15-30).
  • Conclusion: Dolecek directly teaches the concept of managing fluid balance to a specific, predetermined target by calculating net fluid loss and administering a corresponding volume of saline. While it does not explicitly describe personalizing the plasma collection target based on the donor's total plasma volume, it anticipates the limitations in claims 1, 9, and 17 related to calculating and achieving a "target intravascular deficit." This makes it a highly relevant reference that could anticipate a key aspect of the claimed invention.

Based on an analysis of U.S. Patent 10,980,934 ('934 patent) and the state of the art prior to its priority date of May 30, 2017, several of its claims appear vulnerable to an obviousness challenge under 35 U.S.C. § 103. An obviousness rejection requires that the claimed invention would have been obvious to a person having ordinary skill in the art (PHOSITA) at the time the invention was made.

A PHOSITA in this field would be a biomedical engineer or medical professional with several years of experience in the design and operation of apheresis systems and a thorough understanding of hematology and fluid dynamics as they relate to blood donation.

Core Inventive Concepts of the '934 Patent

The central theme of the '934 patent is a move away from generic, weight-based plasma collection limits to a highly individualized and precise methodology. The key steps, as distilled from independent claims 1, 9, and 17, are:

1. Donor-Specific Volume Calculation: Determining a donor's total plasma volume using their specific height, weight, and hematocrit.
2. Personalized Target Volume: Calculating a target plasma collection volume as a specific percentage (e.g., 28.5%) of the donor's calculated total plasma volume.
3. Pure Plasma Measurement: Calculating the volume of pure plasma being collected by actively accounting for and subtracting the volume of the added anticoagulant from the total collected fluid.
4. Targeted Collection Stop: Terminating the collection procedure precisely when the calculated pure plasma volume equals the personalized target volume.
5. Targeted Fluid Replacement: Managing the donor's post-procedure fluid balance by returning other blood components and a specific volume of saline to achieve a predetermined target intravascular deficit.

Obviousness Combination of Prior Art

The claims of the '934 patent would have been obvious based on a combination of prior art that taught: (A) methods for calculating a patient's total blood and plasma volume; (B) standard apheresis systems that monitor fluid volumes using pumps and scales; and (C) the established medical practice of administering saline to manage donor fluid balance.

Reference A: Calculating Patient-Specific Plasma Volume

The concept of calculating a person's total blood volume (and by extension, plasma volume, given a hematocrit value) based on physiological parameters like height and weight was well-established in the medical field long before 2017.

• The '934 patent itself, in the Detailed Description (Col. 9, lines 46-63), points to a known method for calculating total blood volume using the donor's Body Mass Index (BMI). It explicitly references the scientific paper "Lemmens et al., Estimating Blood Volume in Obese and Morbidly Obese Patients, Obesity Surgery, 2006:16, 773-776." This demonstrates that the formula and the scientific basis for calculating a donor-specific blood volume were part of the public domain and known to the art.

A PHOSITA would have recognized that using such established formulas would provide a more accurate, individualized basis for determining safe donation limits than the broad weight categories described as the prior art standard in the '934 patent's "Background Art" section.

Reference B: Standard Apheresis System Capabilities

Prior art apheresis systems, as a matter of routine operation, already contained the necessary hardware and control logic to measure and control fluid volumes.

• Anticoagulant Monitoring: These systems utilize precise pumps to introduce anticoagulant into the whole blood being drawn. As the '934 patent discloses, the volume of anticoagulant can be determined by "a number of rotations of an anticoagulant pump" (Claim 2) or by weight using a scale for the anticoagulant source (Claim 12). These are standard, inherent capabilities of such systems. A PHOSITA would understand that the data from these components (pump rotations or weight change) could be used by the system's controller to calculate the total volume of anticoagulant dispensed.
• Collected Product Measurement: Similarly, prior art systems used weight sensors to measure the total volume of the collected product (plasma plus anticoagulant), as acknowledged in the '934 patent (Col. 7, lines 1-4).

The step of subtracting the known volume of dispensed anticoagulant from the known total volume of collected fluid to find the volume of "pure plasma" is not an inventive leap. It is a simple arithmetic calculation that a PHOSITA would find obvious to implement in a system's software to get a more accurate measurement of the actual therapeutic product being collected.

Reference C: Managing Intravascular Deficit with Saline

The practice of returning saline to a donor to compensate for the removed plasma volume is a fundamental safety feature in plasmapheresis. This is done to maintain the donor's fluid balance (isovolemia) and prevent adverse reactions like fainting or vasovagal reactions.

• The '934 patent describes this as part of its method, aiming for a "target intravascular deficit" (Claim 1). This is simply applying a more precise name and target value to an existing, well-understood safety procedure. A PHOSITA would be well aware of the need for saline compensation and would be motivated to control it precisely to enhance donor safety and comfort.

Motivation to Combine

A person of ordinary skill in the art would have been motivated to combine these known elements for several compelling reasons:

1. Enhancing Donor Safety: The primary motivation would be to improve donor safety. By calculating a donor's specific plasma volume (from Reference A), a precise, individualized collection limit can be set, preventing the over-collection of plasma from smaller donors or those with lower plasma volumes, a risk identified in the '934 patent's background section. Precisely managing the intravascular deficit with saline (Reference C) further contributes to this goal.
2. Maximizing Plasma Yield: For plasma collection centers, there is a strong economic motivation to collect the maximum allowable amount of plasma from each qualified donor. The FDA limits are based on pure plasma volume. Prior art systems, by collecting to a total mixed volume limit, would necessarily under-collect pure plasma, especially from donors with high hematocrit ('934 patent, Col. 7, lines 5-16). By using the hardware in a standard system (Reference B) to calculate and track the pure plasma volume, a PHOSITA would be motivated to combine these techniques to consistently and safely reach the true regulatory limit, thereby maximizing yield and efficiency.
3. Standardization and Predictability: Combining these elements would lead to a more standardized and predictable procedure where the percentage of plasma collected is consistent across donors, rather than varying widely as stated in the background of the '934 patent. This improves quality control and the overall management of the donation process.

In conclusion, the core claims of the '934 patent describe a system and method that combine elements already known and practiced in the art. The calculation of donor-specific plasma volume was known (Reference A), the hardware to measure components was present in apheresis systems (Reference B), and the use of saline for fluid balance was standard practice (Reference C). The motivation to combine these elements to create a safer, more efficient, and more precise plasma collection process would have been readily apparent to a person having ordinary skill in the art before May 2017. Therefore, the claims appear obvious under 35 U.S.C. § 103.

As a senior US patent analyst on May 13, 2026, I have analyzed the prosecution history and family data for US patent 10,980,934. The following report details the patent's term, continuity, and family relationships.

Patent Term and Expiration

• Patent Term Adjustment (PTA): A review of the patent's prosecution history indicates zero (0) days of Patent Term Adjustment. The application was filed on July 16, 2020, and the patent was issued on April 20, 2021, well within the three-year pendency goal set by the USPTO, thus no "B delay" was accrued.
• Patent Term Extension (PTE): There is no indication that this patent has received any Patent Term Extension under 35 U.S.C. § 156, which typically applies to delays in regulatory review for products like drugs or medical devices.
• Projected Expiration Date: The patent's term is calculated from the filing date of the earliest non-provisional application in its family, which is U.S. Application No. 15/608,183, filed on May 30, 2017. Adding 20 years to this date results in a projected expiration date of May 30, 2037. This date is subject to the timely payment of all required maintenance fees and assumes no terminal disclaimers have been or will be filed.

Continuity and Family Data

This patent is part of a larger family of applications sharing a common priority. The direct lineage and related applications are detailed below.

Direct Parentage:

• This patent, issued from application US 16/931,333 (filed July 16, 2020), is a continuation of:
  • Application US 15/793,339 (filed October 25, 2017), which is a continuation-in-part of:
    • Application US 15/608,183 (filed May 30, 2017), which issued as US Patent 10,758,652.

Child and Sibling Applications (Continuations of the Parent Family):
Based on the provided patent data, the family has been further extended through subsequent continuation applications that claim priority back to the original 2017 filing. These include:

• Application US 17/205,400 (filed March 18, 2021), which is expected to issue as US 12,186,474.
• Application US 18/606,761 (filed March 15, 2024), which published as US 2024/0293604 A1.
• Application US 19/077,384 (filed March 12, 2025), which is expected to issue as US 12,377,204.
• Application US 19/275,431 (filed July 21, 2025), which published as US 2025/0345505 A1.

This extensive family of continuation applications indicates an active strategy by the assignee, Haemonetics Corporation, to build upon the foundational technology described in the parent applications.

DEFENSIVE DISCLOSURE AND PRIOR ART GENERATION

RE: System and Method for Collecting Plasma, U.S. Patent 10,980,934
Publication Date: April 26, 2026
Author: Senior Patent Strategist and Research Engineer

This document serves as a defensive publication of technical disclosures intended to enter the public domain and establish prior art. The concepts herein are derived from the core teachings of U.S. Patent 10,980,934 ("the '934 patent") and expanded to render obvious or anticipate potential future patent claims on incremental improvements.

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Derivative Set A: Variations on the Personalized Collection Method (Ref: Claim 1)

A1. Material & Component Substitution: Non-Contact Raman Spectroscopy Sensor

• Enabling Description: The system substitutes the gravimetric scale (weight sensor 195) used for measuring collected plasma volume with a non-contact Raman spectroscopy sensor positioned along the plasma outlet line (222). The sensor continuously irradiates the fluid in the line with a 785 nm laser and analyzes the scattered light. A processor calculates the concentration of key analytes like albumin, immunoglobulins, and the citrate anticoagulant based on their unique Raman spectral signatures. By integrating the known flow rate (from the pump controller) with the real-time concentration measurements, the system calculates the cumulative mass of pure plasma and pure anticoagulant collected, eliminating the need for a physical scale and providing a more direct, real-time chemical measurement of the collected product. The controller terminates collection when the calculated mass of pure plasma reaches the target.
• Mermaid Diagram:

  sequenceDiagram
      participant Donor
      participant Pump
      participant Separator
      participant RamanSensor as Raman Sensor
      participant Controller
  
      Donor->>Pump: Whole Blood
      Pump->>Separator: Anticoagulated Blood
      Separator->>RamanSensor: Plasma + Anticoagulant
      RamanSensor->>Controller: Real-time Concentration Data
      Controller->>Controller: Calculate Pure Plasma Mass
      alt Pure Plasma Mass >= Target
          Controller->>Pump: Stop Collection
          Controller->>Pump: Initiate Return Cycle
      end
  

A2. Operational Parameter Expansion: Microfluidic Organ-on-a-Chip Perfusion

• Enabling Description: The core logic is scaled down for use in laboratory "organ-on-a-chip" (OOC) systems. A microfluidic chip contains cultured human cells (e.g., liver organoids). A micro-pump perfuses the chip with a complex cell culture medium from a reservoir. The system's goal is to maintain a target concentration of a key metabolite (e.g., glucose) while collecting waste products. A micro-sensor (e.g., an electrochemical glucose sensor) in the effluent line measures the real-time metabolite concentration. A controller calculates the total volume of medium consumed and the total mass of metabolite consumed by the cells based on the flow rate and concentration delta. It introduces fresh medium from a second reservoir to maintain the target metabolite level within a tight band (e.g., 5 mM ± 0.1 mM), thereby personalizing the "collection" of waste products based on the real-time metabolic activity of the specific cell culture.
• Mermaid Diagram:

  flowchart TD
      A[Medium Reservoir] -->|Micro-pump| B(Organ-on-a-Chip);
      B --> C{Metabolite Sensor};
      C -->|Concentration Data| D[Controller];
      D -- Adjusts Pump Speed --> A;
      D --> E[Waste Collection];
      F[Fresh Medium] --> D;
      D -- Controls Dosing --> F;
      style D fill:#f9f,stroke:#333,stroke-width:2px
  

A3. Cross-Domain Application: Aerospace Lubricant Purity Management

• Enabling Description: An autonomous system for managing hydraulic lubricant in a deep-space probe. The controller's goal is to extend the life of the lubricant. It calculates the "total lubricant volume" based on system specifications. It determines a "target purity level" (e.g., < 50 ppm of metallic particulates). During operation, a small amount of lubricant is continuously diverted from the main hydraulic loop and passed through an optical particle counter. The controller calculates the "volume of pure lubricant" versus the mass of contaminants. When the contaminant level exceeds a threshold, the controller diverts the lubricant through a filtration unit and then returns it to the main reservoir. This process continues until the calculated "pure lubricant volume" percentage meets the target, at which point the filtration cycle is paused. This is analogous to calculating pure plasma and managing the intravascular deficit.
• Mermaid Diagram:

  graph TD
      subgraph Hydraulic System
          A[Reservoir]
          B[Actuators]
      end
      A --> B;
      B --> A;
      B --> C(Particle Counter);
      C --> D{Controller};
      D -- Contaminant Level > Threshold --> E[Activate Filter];
      C -->|Diverted Flow| F(Filtration Unit);
      F --> A;
      E --> F;
  

A4. Integration with Emerging Tech: AI-Predicted Hydration and Real-Time Target Adjustment

• Enabling Description: The system integrates data from a donor's wearable device (e.g., smartwatch) providing real-time heart rate, heart rate variability (HRV), and skin impedance. A pre-trained machine learning model, running on the controller, uses this data along with the donor's initial height, weight, and hematocrit to create a dynamic model of the donor's hydration state. During the procedure, if the model detects signs of dehydration (e.g., rising heart rate, falling HRV), the controller automatically recalculates the donor's total plasma volume in real-time and adjusts the target plasma collection volume downward to a more conservative percentage. This AI-driven feedback loop ensures the collection target is continuously optimized for donor safety based on their real-time physiological response.
• Mermaid Diagram:

  flowchart LR
      subgraph Donor
          A(Wearable Sensor)
      end
      subgraph Apheresis Machine
          B(Controller)
          C(ML Model)
      end
      A -- Real-time Vitals --> B;
      B -- Feeds Vitals to --> C;
      C -- Dynamic Hydration State --> B;
      B -- Adjusts --> D[Target Plasma Volume];
      style C fill:#ccf,stroke:#333,stroke-width:2px
  

A5. The "Inverse" or Failure Mode: Safe Intravascular Deficit Mode

• Enabling Description: A "Safe Deficit" mode is designed for situations with sensor unreliability or for particularly sensitive donors. In this mode, the system does not target a specific plasma volume. Instead, it targets a maximum intravascular deficit, set to a conservative value like 300 mL. The controller monitors the volume of whole blood drawn and the volume of red blood cells and other components returned. It calculates the intravascular deficit in real-time as (Volume_Drawn - Volume_Returned). Plasma is collected continuously, but the moment this calculated deficit reaches the 300 mL limit, the controller immediately stops the draw pump and initiates the saline return cycle, regardless of how much plasma has been collected. This method inverts the primary goal from yield to a guaranteed low-impact donor experience.
• Mermaid Diagram:

  stateDiagram-v2
      [*] --> Drawing: Procedure Start
      Drawing: enter / Calculate Deficit = V_drawn - V_returned
      Drawing --> Safe_Return: [Deficit >= 300mL]
      Drawing --> Drawing: [Deficit < 300mL] Collect Plasma
      Safe_Return: Stop Draw, Return Saline
      Safe_Return --> [*]: End Procedure
  

---

Derivative Set B: Variations on the System and Controller (Ref: Claim 9)

B1. Material & Component Substitution: Modular Disposable Cassette with Non-Contact Magnetic Drive

• Enabling Description: The entire extracorporeal circuit (inlet/outlet lines, pumps, pressure sensors, separation chamber) is integrated into a single, disposable cassette molded from medical-grade polycarbonate and sealed with a flexible thermoplastic elastomer membrane. The separation chamber is a centrifugal bowl that contains a magnetically-coupled impeller at its base. The non-disposable base unit contains no peristaltic pump rollers; instead, it uses a series of pneumatic valves to press on the cassette's membrane to drive fluid flow. The centrifuge motor is replaced by a non-contact magnetic drive that spins the impeller inside the sealed bowl without any physical contact, reducing heat generation and eliminating the need for a rotary seal, thus lowering the risk of contamination and hemolysis.
• Mermaid Diagram:

  classDiagram
      class DisposableCassette {
        +polycarbonate_body
        +TPE_membrane
        +integrated_tubing
        +magnetic_impeller_bowl
      }
      class BaseUnit {
        +pneumatic_controller
        +non_contact_magnetic_drive
        +system_controller
        -actuatePneumaticValves()
        -spinMagneticDrive()
      }
      BaseUnit "1" -- "1" DisposableCassette : engages
  

B2. Cross-Domain Application: AgTech Automated Nutrient Dosing for Hydroponics

• Enabling Description: A system for large-scale hydroponic farms. A central controller calculates the "total nutrient volume" required for a crop cycle based on plant type, age, and environmental sensors (light, temp, CO2). Each day, it draws nutrient solution that has been circulated through the plant beds into a separation and analysis module. This module uses ion-selective electrodes to measure the concentration of key nutrients (N, P, K). The controller calculates the "pure nutrient" uptake by the plants. It then calculates a target replenishment volume, introduces precise doses of concentrated N, P, and K stock solutions into the main reservoir, and adds water to compensate for evaporation, thereby achieving a "target nutrient deficit" of zero.
• Mermaid Diagram:

  sequenceDiagram
      participant PlantBeds
      participant AnalysisModule
      participant Controller
      participant DosingPumps
  
      PlantBeds->>AnalysisModule: Circulated Solution
      AnalysisModule->>Controller: Nutrient Concentrations
      Controller->>Controller: Calculate Nutrient Uptake
      Controller->>DosingPumps: Command Replenishment Doses
      DosingPumps->>PlantBeds: Add Concentrated Nutrients & Water
  

B3. Integration with Emerging Tech: Blockchain-Verified Cold Chain for Plasma

• Enabling Description: The system controller is enhanced with an IoT module that includes a temperature sensor, GPS, and a cryptographic co-processor. Upon procedure completion, the controller generates a unique digital token (e.g., an ERC-721 token on an Ethereum-compatible blockchain) representing the collected unit of plasma. This token immutably stores the donor ID hash, the volume of pure plasma collected, the machine ID, and the timestamp. As the plasma unit is transported and stored, the IoT module continuously monitors its temperature and location, appending these readings to the token's metadata on the blockchain. This creates a verifiable, unbroken cold chain record from collection to fractionation, ensuring the integrity and provenance of the final product.
• Mermaid Diagram:

  flowchart TD
      Start((Collection Complete)) --> A{Generate Plasma NFT};
      A --> B[Write Collection Data to Blockchain];
      B --> C{Transport & Storage};
      C --> D[IoT Sensor Monitoring];
      D --> |Temp & GPS Data| E{Append Data to NFT Metadata};
      C -- Loop --> D;
      E --> F((End of Supply Chain));
      style A fill:#bbf,stroke:#333,stroke-width:2px
  

B4. The "Inverse" or Failure Mode: Failsafe Gravity-Feed Return System

• Enabling Description: The system includes a failsafe return mechanism that operates without electrical power. The disposable set is designed such that the blood processing components (bowl, pumps) are physically elevated above the donor's access site. In the event of a catastrophic power failure, a normally-closed solenoid valve, held shut by power, automatically opens. This action bypasses the pumps entirely and opens a direct, wide-bore tubing path from the bottom of the separation bowl back to the donor. The entire volume of the extracorporeal circuit is then returned to the donor purely by gravity. The controller's only role in this failure mode is to de-energize the valve. This ensures the donor's blood volume is safely restored even if the controller and all pumps fail simultaneously.
• Mermaid Diagram:

  stateDiagram-v2
      state "Normal Operation" as ON
      state "Power Failure" as OFF
  
      [*] --> ON
      ON --> OFF: Power Loss
      OFF --> [*]: Power Restored
  
      state OFF {
          direction LR
          [*] --> OpenValve
          OpenValve --> GravityReturn: Solenoid Valve De-energized
          GravityReturn --> DonorSafe
      }
  

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Combination Prior Art Scenarios

1. Combination with MQTT Protocol: The apheresis system's controller (as in Claim 9) is configured as an MQTT client. It publishes real-time operational data (e.g., draw pressure, return pressure, anticoagulant flow rate, current collected volume, calculated pure plasma volume, machine status, and error codes) to a central MQTT broker within the donation center's network. The data is published to structured topics (e.g., devices/apheresis/bay04/pressure/draw). This allows any authorized system, such as a central monitoring dashboard or the facility's Laboratory Information System (LIS), to subscribe to these topics and receive real-time updates without custom integration, using the open-source and widely adopted MQTT standard for M2M communication.

2. Combination with TensorFlow Lite Framework: The method for calculating the volume of pure plasma (as in Claim 1) is enhanced by an on-device machine learning model built with TensorFlow Lite. The model is trained to detect early signs of hemolysis by analyzing high-frequency data from the optical line sensor (185). Instead of just detecting fluid density changes (plasma vs. platelets), the model analyzes the full spectral data from the sensor. It can identify the subtle spectral signature of free hemoglobin in the plasma line, indicating red blood cell damage. If hemolysis is detected, the controller can flag the collected product and alert the operator, improving product quality and donor safety, all without requiring a network connection for the AI inference.

3. Combination with DICOM Standard: At the conclusion of a plasma collection procedure, the system generates a DICOM (Digital Imaging and Communications in Medicine) Structured Report. This is not an image but a standardized data object. The report contains all key information from the procedure: Patient Information (name, ID), Procedure Information (date, time, machine ID, operator ID), Input Parameters (height, weight, initial hematocrit), Calculated Values (total plasma volume, target collection volume), and Final Results (volume of pure plasma collected, volume of anticoagulant used, volume of saline returned, final intravascular deficit). This DICOM object can be sent directly to the facility's PACS (Picture Archiving and Communication System) or VNA (Vendor Neutral Archive), where it becomes a permanent part of the donor's medical record, viewable and accessible alongside MRIs, CT scans, and other medical reports.